Case Specialist Philippines 2

Group ProductLife; Philippines; Hybrid; PHP 400,000 - 650,000; Full time

Job summary

ProductLife Group is seeking a Case Specialist (Pharmacovigilance) to join the hub and contribute to quality control, medical evaluation of reports, and data entry of vigilance cases.

The role requires a Doctor of Pharmacy, a minimum of 3 years in a similar position, and solid knowledge of GVP/GCP and regulatory drug safety requirements. Hybrid & flexible working with life sciences clients.

Qualifications

• Doctor in Pharmacy/ Pharmacist by training
• Minimum 3 years of experience in a similar position
• Previous experience working to deadlines
• Database experience
• Clinical and Post Marketing case processing experience
• Pharmaceutical background – strong understanding of GVP, GCP, FDA and regulatory requirements related to drug safety
• Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessment

Responsibilities

• Quality control of vigilance cases and medical evaluation of reports
• Data entry of vigilance cases into ad hoc databases as required
• Follow-up requests of vigilance cases by phone or email
• Pre-analysis of complex cases prior to data entry
• Medical evaluation of files: coding, causality, seriousness, and submission needs
• Close vigilance files and coordinate with Data Manager and clients
• QC for clinical/post-marketing cases and act as key contact for customers

Skills

Database experience

Knowledge of current regulations

Process oriented

Rigorous and team work

Microsoft Office tools

Multitasking

Flexibility

Excellent communication skills

Education

Doctor in Pharmacy/ Pharmacist by training

Job description

Job Description

ProductLife Group is looking for Case Specialist (Pharmacovigilance) to join and contribute to the activities of the hub.

Responsibilities

Responsible for the Quality control of vigilance cases Medical evaluation of reports Data entry of vigilance cases in ad hoc databases or in other formats agreed with the client Follow-up request of vigilance cases by phone/mail Pre-analysis of complex cases prior to data entry Medical evaluation of files on: Coding (according to applicable dictionary) Causal relationship between the effects and the intake of suspect products (according to applicable method) The expected/listed or unlisted nature of the events/effects/incidents The seriousness of the events/effects/incidents and the case Identification of submission requirements for each case Validation of certain documents produced by the Data Manager/ Vigilance Associate / documentalist (phone call forms, etc) Closing of vigilance files Identification of requirements and applicable changes to set up ICSR/MLM filters Analysis of inclusion / exclusion of EV/MHRA cases To perform QC for clinical/post-marketing cases Key Contact for specific customers (with the support of an Activity Manager or the Line Manager)

Education & Experience

• Doctor in Pharmacy/ Pharmacist by training


• Minimum 3 years of experience in a similar position


• Previous experience working to deadlines


• Database experience


• Clinical and Post Marketing case processing experience


• Pharmaceutical background – strong understanding of GVP, GCP, FDA and regulatory requirements related to drug safety.


• Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessment.

Skills

• Database experience preferred


• Knowledge of current regulations


• Process oriented


• Rigorous and ability to work in a team


• Use of Microsoft Office tools


• Ability to multitask


• Flexibility


• Excellent communication skills

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